Presentation on theme: "RK Gupta, Head Intellectual Property Management Division Council of Scientific & Industrial Research India Management of Intellectual."— Presentation transcript:
RK Gupta, Head Intellectual Property Management Division Council of Scientific & Industrial Research India Management of Intellectual Property (IP) in CSIR Laboratories CSIR-WIPO Workshop on Negotiating Technology Licensing Agreements India Habitat Centre, New Delhi, 4-8 July 2005
CSIR Mission To provide scientific industrial R&D that maximizes the economic, environmental & societal benefits for the people of India Serve the Nation
IP IN CSIR: CHRONOLOGY 1942: Formation of CSIR:Applied & Industrial R&D-Central Patent Cell-Indian Patents-Individual Initiative-Sporadic Licensing of Technology 1970: New Patents Act: Flip To Pharma, Food & Chemical Sectors- Patent Unit- Greater Awareness Creation – Laboratory Initiative- No. 1 Position in India-Licensing of Technology including Patents-Sporadic Foreign Filing 1995: India joins WTO 1998: India joins Paris Convention/PCT 1999: Patent amendment to provide EMR retrospectively from 1/1/95
…. Contd 2003: 2 nd amendment in Patents Act TK not patentable Term of Patent – 20 years Deferred Examination 18 months publication Process patents for biotech inventions Patent Tribunal Set up at Chennai EMR granted Patents Amendment Act 2005 effective from
…….. Contd 1999 – 2004: Plant Varieties and Farmers Rights Act Passed Designs, TM /Copyright Acts updated and at par with developed world GI Registry Set up at Chennai 200, 000 designations for India under PCT Modernization of Indian Patent Office and its branches Boost to patenting of drugs, pharmaceuticals, botanicals and bio-tech inventions in CSIR
IP Management DG, CSIR LAB DIRECTOR IPMD IPM CELL Staff 28 (Scientists – 13, Technical Support:7, Others:8) Policy Planning All Techno-legal matters (Capturing. drafting, Filing, Prosecution, Litigation) Assisting labs in Valorization Awareness 1 Scientist and other staff Capture Patent Search Evaluation+Assessment Gap Filling Internal preliminary Drafting Infringement Monitoring Valorization
Acquisition & Protection IP Cell In each Lab Disclosures and recordals Publications Scrutinized For IP Scrutiny for patenting Early Spotting of IP and its Capture Assessment & Filling up of Gaps Patent Search and Preliminary Drafting Inputs for examination and maintenance
……….. Contd IPMD Awareness, training, capture, disclosure and patentability Assessment, drafting, filing, and prosecution of Indian and Foreign Patents, litigation. Foreign Protection Where to protect, Route – Attorneys, Maintenance, Potential, Expenses, Duration
Patent Filing in Different Countries Potential Commercial Opportunities Product/Process Life Time Alternative Protective Mechanisms Cost of Patenting Defensive/Deterrent Position with respect to Competitors Feasibility of Policing and Enforcement Potential for Trading the Patent Publicity/Advertisement gains Force Competitors to invest in getting around the patent
Monitoring Structure GOVERNMENT – Overall CSIR Targets DG, CSIR – Labwise and CSIR Targets IPMD - Labwise and CSIR Targets IPMD - Director/IPMC/Division/Unit/Engg./SC DIRECTOR – Division/Unit Targets IPMC - Division/unit Targets/Engg./SC
Stimulating Innovation Individuals Career Advancement Certification From CEO Monetary Incentives: Sharing Of Monies Realized Lab Requirement for performance appraisal Competitive pressure CSIR Target setting publicly National expectation
Meeting post WTO challenges To meet the challenges under new IP regime, CSIR announced its IP Policy in 1996 which envisaged: The maximization of the benefits to CSIR from its intellectual property by stimulating higher levels of innovation through a judicious system of rewards, ensuring timely and effective legal protection for its IP and leveraging and forging strategies alliances for enhancing the value of its IP. CSIR sets up its own targets of developing a portfolio of 1000 Indian and 500 Foreign patents by 2001.
ELEMENTS OF IP MANAGEMENT POLICY Awareness, Motivation & Promotion IP Management Skills Matrices For Performance Acquisition & Protection Audit & Valuation Valorization Incentives & Rewards Monitoring & Review
Performance of CSIR
Current Status of CSIRs IP
CSIR Patent filing
Top PCT applicants in 2002 RankApplicantCountryNo 1Council of Scientific & Industrial Research India186 2Samsung Electronic Co.Rep of Korea184 3Biowindow Gene Development IncChina136 4LG electronics IncChina125 5Huawaei Technologies Co.China84 6Ranbaxy Laboratories Ltd.India56 7LG Chem Ltd.Rep of Korea47 8SAE Magnetics (H.K.) Ltd.China31 9The National University of SingaporeSingapore28 10Philips Electronics Singapore PTE Ltd.Singapore24
*CSIR filed 213 PCT applications in 2003 PositionOrganisation 1LG Electronics (Republic of Korea) 2Samsung Electronics Co. Ltd. (Republic of Korea) 3Council of Scientific and Industrial Research (CSIR) (India) Top PCT applicants in 2003
US patents granted to CSIR
% Share of CSIR in the total US Patents granted to Indians excluding foreign assignees
Patent Portfolio Development Expansion of Patent Coverage (Improvement Patents) Protection of New Uses/Combinations Protection of Plant Varieties/Software Creation of Buffer Zone Surrounding Patents
Some key portfolios Bio-enhancers Herbal Formulations - anti-diabetic - anti-oxidant - Hepatoprotective - Immunomodulation - Weight Reduction Standardization of herbal products Anti-malarials and anti-cancer compounds and formulations Food products and processes
Biotechnology and bio-informatics Products Leather technology Optical Fibre Drugs & Pharmaceuticals Nanotechnology Polymers Aerospace others Some key portfolios
CSIR Patents on Drugs/Pharmaceuticals/Chemicals/ Biotechnology during NFYP & TFYP
An integrated approach Traditional Medicine Modern Medicine Modern Science The Golden Triangle - Dr. Mashelkars Concept
Current Priorities Valorization of IP
Clustering Filling Gaps Bubble Patents Portfolio formation Valuation Forging Strategic Alliance Licensing/Bartering/Sale CSIR Lab Agents Public-Private Partnership Regulating Access Strengthening Linkages with Industry Adopting new models for valorization of IP Enforcement - Action against Infringement Valorization of IP
Reaching the Current Stage How ? Training of IPMD Scientists Training of CSIR IP Coordinators and scientists by leading US and European patent attorney firms, and, consultants; WIPO, Patent Office Experts from USPTO, EPO and Japan. Experts from Multinationals (Pfizer) Training of scientists in patent search, initial assessment of disclosure, preparation of provisional patents and internal evaluation Training of scientists in patent examination Training of scientists in valorization, licensing, arbitration and litigation.
Reaching the Current Stage Model for other publicly funded organisations Model for industry Support System for Universities through formal and informal channels Role in impacting national IP Policies Role in formulating Universities IP Policies
IP Licensing: Ownership of IP CSIR CSIR/Joint
IP Licensing: Approvals for Licensing of IP Director/Management Council DG, CSIR
Licensing of IP Direct Licensing by the Laboratory Licensing of IP through TTAs/Business consultants/NRDC
Licensing IP: Pricing of IP a. Cost of development b. Cost of securing the IP c. Cost of maintaining the IP d. Intellectual Fee e. Service Tax
Sharing of Premia/Royalty received from Licensing of IP/Knowledgebase CSIR60% INVESTIGATORS40%
Distribution of Monies Realised Innovators & Principal Contributors S&T and other staff who contribute direct inputs to the specific development/activity Remaining Staff of the laboratory CSIR Welfare fund (maintained at HQ)
IP Licensing Success Stories
Streptokinase -Success Stories in Licensing - I Increasing No. of people suffering from heart diseases worldwide and specially in India Cause of death – development of a blood clot causing vascular blockage Prevention by timely intravenous administration of a thrombolytic agent Problem-Non availability of affordable thrombolytic agent within six hours of the onset of heart attack Drugs commonly used are tissue plasminogen activator, urokinase and streptokinase Market demand for thrombolytics Rs. 1 bn Streptokinase - 80% of the demand Growth in demand - 20% annualy
Success Stories in Licensing - I IMTECH developed first indigenous clot buster drug STPase and it was launched in market in 2000 through Cadila Pharma IMPACT – crash down of the price from Rs. 3,500 to Rs. 2,000 per dose Milestone payments based on the demonstration of the technology i.e 98% purity at 20/100 L scales Royalties started from the date of commercial production
Success Stories in Licensing - I Further R&D work by the lab for the production of recombinant natural type SK at a level nearly 10 times of natural SK The product is licensed and regulatory testing for rDNA based theraupatics has been completed and this drug is likely to be available at most affordable cost. Licensing model - milestone payments/royalties Licensing possible because of IP protection in India, USA & Europe
Success Stories in Licensing - II NCL-GE Alliance – originated in GE supported the R&D at NCL Alliance operated for over 9 years successfully and emerged as a paradigm in relationship management in R&D. Cash flow to NCL from GE of around USD 8.5 m over the period to Exposure to and training of NCL scientists to world class R&D management practices.
Success Stories in Licensing - II Building up of world class facilities and resources in NCL Attracting and hiring of talented young scientists New contract research opportunities with multinational companies Diffusion of ideas and generic methods developed to Indian industries Half a dozen patents assigned to GE CSIR owns several patents based on generic ideas developed while interacting with GE having relevance to systems other than polycarbonates
Success Stories in Licensing - II Ushering into NCL the understanding, importance and culture of IPR. Spin off: THPE [1,1,1-Tris(4-hydroxyphenyl) ethane] is a branching agent used in the synthesis of high grade polycarbonates with properties of high transparency, good mechanical and high parison strength. Hoechst Celanese USA, was the only supplier of THPE to the global market. In 1994, NCL initiated a program, funded by GE aimed at developing a proprietary process for THPE.
Success Stories in Licensing - II Patents were filed in India and abroad Excel has exported THPE valued at around Rs. 30 Crore over the three year period NCL has received US $ 50,000 as license fee and royalty payment of around US $ 1,00,000. NCLs endeavour has led to an Indian firm challenging and breaking global monopoly of a single supplier.
Success Stories in Licensing - III United States Patent 6,893,479 (CSMCRI) Integrated method for production of carrageenan and liquid fertilizer from fresh seaweeds An integrated method is developed to utilize to a maximum extent the fresh biomass of seaweeds such as Kappaphycus alvarezii that can be crushed to release sap and where the sap is useful as a potent liquid fertilizer after suitable treatment with additives and dilution while the residue is a superior raw material for extraction of κ-carrageenan, thereby enhancing the value of the seaweed. Other advantages of the invention include a reduced drying time and drying area to obtain the raw material for κ-carrageenan production in dry and storable form, a reduced cost of transporting and storing this raw material because of its lesser bulk, easier handling due to its free flowing granular nature, and its direct use for gel preparation in certain applications
Success Stories in Licensing - III CSIR licenses Sea Weed Technology to Pepsico A plant growth harmone and regulator is derived from fresh Sea Weed grown along the shoreline. Liquid Sea Weed Fertilizer increases yields from same seed by 10% for wheat, 30% for peddy, % for fruits and vegetables to 35% for corn and chana, BT cotton 20%, Banana for 19%. Patent applications fined in India, US and other countries
Success Stories in Licensing - III Trials in Punjab, Andhra Pradesh and Gujarat. Realizing the employment generation potential of aqua-agriculture, DBT, ICAR other government deptts. are now pushing sea weed cultivation as a promising money spinner for rural population Social Impact: Hundreds of women along the shoreline can look forward to earning more than Rs. 12,000 a month as pepsi suppliers.
Success Stories in Licensing - IV Mint oil is used mainly for producing menthol and the by-product dementholised oil (DMO) which finds uses in pharmaceutical and cosmetic industry. Menthol has a cooling, refreshing aroma and antiseptic properties. The current world-wide consumption of natural and synthetic l-menthol in the cosmeticeutical and cigarette industries is estimated at about 15,000 and 3,000 metric tons, respectively.
Success Stories in Licensing - IV About 15 years ago bulk of l-menthol rich essential oil of M. arvensis for international use came from Brazil and China. Later China and India became the main exporters. In the last few years India has come to occupy 1 st position in the trade of M. arvensis essential oil and its products.
Success Stories in Licensing - IV Social Impact: Estimated area and production of menthol mint during YearArea (ha)Production of oil (t) # Employment Generation # Enhancement in rural earning
Success Stories in Licensing - IV A new and distinct variety "Himalaya" of Mentha arvensis, (US Patent No. PP10,935) has been developed by CIMAP characterized by its higher yield of oil which is rich in menthol; improved regeneration potential; tolerance to rust, alternaria leaf blight, corynespora leaf spot, and powdery mildew; vigorous growth; deep green broad thick leaves; and pinkish white flowers.
Success Stories in Licensing - IV CIMAP developed another novel mint plant "Kosi" (US Patent No. PP12,426) Characterized by its high biomass and high oil yield with synchronous branching giving globular shape to the canopy for equal distribution of sunlight to the lower leaves
Success Stories in Licensing - IV Another novel high menthol producing plant "Saksham" (US Patent No. PP13,279) developed by CMIAP obtained through metabolic engineering, a unique method of screening of the somaclones in poison agar medium containing toxic level of menthol. Tolerant to high concentration of menthol in cultures and hence possesses property of accumulating more menthol per unit leaf mass
Success Stories in Licensing - IV A new and distinct interspecific mint hybrid "Neerkalka" (US Patent No. 12,030) developed by CIMAP through sexual crossing between improved Mother plant Mentha arvensis (cv Kalka) and pollen plant Mentha spicata (cv Neera). The hybrid is propagated vegetatively by suckers or stem cuttings and is stable for commercial cultivation.
Success Stories in Licensing - V United States Patent 6,858,141 (NCL) Process for the preparation of ultrafiltration membranes of polyacrylonitrile, using malic acid as an additive A process for the preparation of ultrafiltration membranes from polyacrylonitrile using malic acid as additives, with said membrane of molecular weight ranging between 80 to 180K, showing high purification and water permeating ability. # Cost of water purification (Bacteria + Virus free) few paise per litre as compared to Rs. 10 per litre of mineral water # Licensed to the industry recently; Social Impact- Very high
Other Success Stories from CSIR Each lab created several such success stories in recent years Licensing was possible because of IP protection Value realization is a long term process Several proposals for IP licensing in the pipeline – all because of IP protection nationally and internationally.
Doing Business with IP – Challenges Public-Private Partnership Regulating Access Strengthening Linkages with Industry Venture Capital Competing at a fast pace Working towards Technology oriented systems of Innovation Adopting new models for valorization of IP Focusing on Socially relevant technologies Adopting best practices in IP Licensing